Afatinib in locally advanced/metastatic NSCLC harboring common EGFR mutations, after chemotherapy: a Phase IV study
Sumitra Thongprasert1, Sarayut L Geater2, Dana Clement3
1Medical Oncology Unit, Wattanosoth Hospital & Bangkok Hospital Chiang Mai (BDMS), Chiang Mai 50000, Thailand.
Aim:
The current study evaluated the efficacy and tolerability of second-line afatinib in patients with EGFR mutation-positive (EGFRm+) non-small-cell lung cancer (NSCLC) following chemotherapy.
Patients & Methods:
In this open-label, single-arm Phase IV study, patients with EGFRm+ (Del19/L858R) NSCLC who had progressed following platinum-based chemotherapy received afatinib (starting dose 40 mg/day). The primary end point was confirmed objective response.
Results:
60 patients received afatinib for a median duration of 11.5 months. 50% of patients had a confirmed objective response, of median duration 13.8 months. Median progression-free survival was 10.9 months. The most common treatment-related adverse events were diarrhea (72%), rash (28%) and paronychia (23%).
Conclusion:
Our data support the use of afatinib (40 mg/day) as an effective and well-tolerated second-line treatment in EGFRm+ NSCLC.
Insights
Second-line afatinib demonstrated efficacy in non-small-cell lung cancer (NSCLC) patients with EGFR mutations. This treatment showed a 50% objective response rate and was well-tolerated, supporting its use after chemotherapy.
Area of Science:
- Oncology
- Pharmacology
Background:
- Non-small-cell lung cancer (NSCLC) with EGFR mutations presents treatment challenges.
- Chemotherapy resistance necessitates effective second-line therapies.
Purpose of the Study:
- To evaluate the efficacy and tolerability of afatinib as a second-line treatment.
- To assess afatinib's impact on objective response and progression-free survival in EGFR-mutated NSCLC.
Main Methods:
- Open-label, single-arm Phase IV study.
- 60 patients with EGFR mutation-positive NSCLC received afatinib 40 mg/day post-chemotherapy.
- Primary endpoint: confirmed objective response.
Main Results:
- 50% objective response rate with a median duration of 13.8 months.
- Median progression-free survival was 10.9 months.
- Common adverse events: diarrhea (72%), rash (28%), paronychia (23%).
Conclusions:
- Afatinib (40 mg/day) is an effective second-line treatment for EGFR mutation-positive NSCLC.
- Afatinib demonstrates good tolerability in this patient population.
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